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The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines (MSF)

Primary Purpose

Diabetes, Dyslipidemia, Inflammation

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Sponsored by
Medical University of Silesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes

Eligibility Criteria

35 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age (35-64yr)
  • Primary hyperlipidemia (Total cholesterol >200mg/dl, Triglycerides >150mg/dl)
  • Type 2 Diabetes
  • For women:
  • Menopause (>12 months)
  • Post hysterectomy
  • Mechanical contraception
  • Obtained informed consent

Exclusion Criteria:

  • Secondary hyperlipidemia
  • Morbid obesity (BMI>40kg/m2)
  • Alcohol or drug abuse
  • Acute or chronic inflammation
  • Congestive Heart Failure (NYHA III or IV)
  • Unstable Ischaemic Heart Disease
  • Moderate or severe hypertension
  • Cancer in less than 5 years
  • Chronic kidney disease (stage III-V)
  • Liver failure
  • Oral contraception
  • Not compliant patient
  • Laboratory results:
  • alanine transferase (>3xULN)
  • creatine kinase (>5xULN)
  • haemoglobin (<10/dl)
  • PLT (<100G/l)
  • WBC (<3,5G/l or >10G/l)

Sites / Locations

  • Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

M1000 S10 F100

M1000 S10 F267

M1000 S40 F100

M1000 S40 F267

M2500 S10 F100

M2500 S10 F267

M2500 S40 F267

M2500 S40 F100

Therapeutic Lifestyle Change

Arm Description

metformin 1000mg, fenofibrate 100mg and simvastatin 10mg

metformin 1000mg, fenofibrate 267mg and simvastatin 10mg

metformin 1000mg, fenofibrate 100mg and simvastatin 40mg

metformin 1000mg, fenofibrate 267mg and simvastatin 40mg

metformin 2500mg, fenofibrate 100mg and simvastatin 10mg

metformin 2500mg, fenofibrate 267mg and simvastatin 10mg

metformin 2500mg, fenofibrate 267mg and simvastatin 40mg

metformin 2500mg, fenofibrate 100mg and simvastatin 40mg

Only therapeutic lifestyle change

Outcomes

Primary Outcome Measures

Antiinflammatory effects of combined antidiabetic and hypolipemic treatment
As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines: Interleukin 1 TNF alpha Interleukin 6 Interleukin 10 hsCRP

Secondary Outcome Measures

Insulin sensitivity
Assesed by HOMA (Homeostatic Model of Assessment)
Coagulation parameters
Assessed using: Fibrinogen PAI-1

Full Information

First Posted
April 7, 2010
Last Updated
July 5, 2012
Sponsor
Medical University of Silesia
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1. Study Identification

Unique Protocol Identification Number
NCT01101204
Brief Title
The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines
Acronym
MSF
Official Title
Effects of High and Low Doses of Metformin, Fenofibrate and Simvastatin, Administered Together and in Sequence With Lifestyle Intervention on Lipid Profile, Glucose Metabolism, Low-grade Inflammation and Hemostasis in Patient's Blood Plasma in Type 2 Diabetic Patients With Serious Mixed Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Silesia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Dyslipidemia, Inflammation, Cytokines

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M1000 S10 F100
Arm Type
Active Comparator
Arm Description
metformin 1000mg, fenofibrate 100mg and simvastatin 10mg
Arm Title
M1000 S10 F267
Arm Type
Active Comparator
Arm Description
metformin 1000mg, fenofibrate 267mg and simvastatin 10mg
Arm Title
M1000 S40 F100
Arm Type
Active Comparator
Arm Description
metformin 1000mg, fenofibrate 100mg and simvastatin 40mg
Arm Title
M1000 S40 F267
Arm Type
Active Comparator
Arm Description
metformin 1000mg, fenofibrate 267mg and simvastatin 40mg
Arm Title
M2500 S10 F100
Arm Type
Active Comparator
Arm Description
metformin 2500mg, fenofibrate 100mg and simvastatin 10mg
Arm Title
M2500 S10 F267
Arm Type
Active Comparator
Arm Description
metformin 2500mg, fenofibrate 267mg and simvastatin 10mg
Arm Title
M2500 S40 F267
Arm Type
Active Comparator
Arm Description
metformin 2500mg, fenofibrate 267mg and simvastatin 40mg
Arm Title
M2500 S40 F100
Arm Type
Active Comparator
Arm Description
metformin 2500mg, fenofibrate 100mg and simvastatin 40mg
Arm Title
Therapeutic Lifestyle Change
Arm Type
Placebo Comparator
Arm Description
Only therapeutic lifestyle change
Intervention Type
Drug
Intervention Name(s)
Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg
Intervention Description
Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
Primary Outcome Measure Information:
Title
Antiinflammatory effects of combined antidiabetic and hypolipemic treatment
Description
As inflammatory effects we measure the difference in serum concentration before and after the treatment of the following proinflammatory cytokines: Interleukin 1 TNF alpha Interleukin 6 Interleukin 10 hsCRP
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Insulin sensitivity
Description
Assesed by HOMA (Homeostatic Model of Assessment)
Time Frame
30 days
Title
Coagulation parameters
Description
Assessed using: Fibrinogen PAI-1
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age (35-64yr) Primary hyperlipidemia (Total cholesterol >200mg/dl, Triglycerides >150mg/dl) Type 2 Diabetes For women: Menopause (>12 months) Post hysterectomy Mechanical contraception Obtained informed consent Exclusion Criteria: Secondary hyperlipidemia Morbid obesity (BMI>40kg/m2) Alcohol or drug abuse Acute or chronic inflammation Congestive Heart Failure (NYHA III or IV) Unstable Ischaemic Heart Disease Moderate or severe hypertension Cancer in less than 5 years Chronic kidney disease (stage III-V) Liver failure Oral contraception Not compliant patient Laboratory results: alanine transferase (>3xULN) creatine kinase (>5xULN) haemoglobin (<10/dl) PLT (<100G/l) WBC (<3,5G/l or >10G/l)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krzysztof Labuzek, MD, PhD
Phone
+48 32 252 39 02
Email
lbuldak@gmail.com
Facility Information:
Facility Name
Department of Clinical Pharmacology
City
Katowice
ZIP/Postal Code
40752
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krzysztof Labuzek, MD, PhD
Phone
+48 32 252 39 02
Email
lbuldak@gmail.com
First Name & Middle Initial & Last Name & Degree
Łukasz Bułdak, MD
First Name & Middle Initial & Last Name & Degree
Bogusław Okopień, MD, PhD
First Name & Middle Initial & Last Name & Degree
Krzysztof Labuzek, MD, PhD

12. IPD Sharing Statement

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The Effects of Hypolipemic and Antidiabetic Treatment on Cytokines

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